Biodegradable Eustachian tube support and biodegradable Eustachian tube support system

Abstract

This invention provides a biodegradable Eustachian tube support and a biodegradable Eustachian tube support system. The biodegradable Eustachian tube support includes a connected Eustachian tube receiving portion and a middle ear receiving portion. The Eustachian tube receiving portion, when in an expanded state without external force, is tubular and has a hollow, through-hole cavity. After implantation into the Eustachian tube, the Eustachian tube receiving portion is in the expanded state to open the Eustachian tube. The middle ear receiving portion includes a linear base structure. When not subjected to external force, the base structure itself forms a three-dimensional winding shape in space. After implantation into the tympanic cavity, the base structure forms the three-dimensional winding shape, filling the area of ​​the tympanic cavity adjacent to the Eustachian tube to maintain communication between the tympanic cavity and the Eustachian tube, while preventing the Eustachian tube receiving portion from sliding. Both the Eustachian tube receiving portion and the base structure are made of biodegradable materials.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a biodegradable Eustachian tube stent and a biodegradable Eustachian tube stent system. Background Technology

[0002] Obstructive eustachian tube dysfunction (OETD) is a common ear disease with an adult incidence of approximately 4.6%. It is caused by complex eustachian tube abnormalities leading to middle ear ventilation dysfunction and is the root cause of many middle ear diseases. Long-term eustachian tube dysfunction can lead to chronic secretory otitis media, chronic suppurative otitis media, cholesteatoma, and adhesive otitis media, causing complications such as persistent ear fullness, tympanic membrane perforation, otorrhea, and hearing impairment, severely impacting patients' quality of life and imposing a heavy economic burden on families and society. Currently, traditional clinical treatments for eustachian tube dysfunction include medication, eustachian tube inflation, and tympanocentesis / tube placement. These methods have some effect on early-stage eustachian tube dysfunction, but they are difficult to effectively restore eustachian tube function and are prone to relapse. In addition to refractory eustachian tube dysfunction, post-radiotherapy eustachian tube dysfunction requires long-term tympanostomy tube placement, and the incidence of complications such as ear discharge, tympanic membrane perforation, and cholesteatoma is as high as 28.9% to 60%, which also challenges the efficacy of conventional treatments.

[0003] Eustachian tube balloon dilation is a treatment method that has emerged in recent years, mainly improving Eustachian tube function by dilating the cartilaginous portion of the Eustachian tube. However, some patients with refractory Eustachian tube dysfunction still do not respond to this surgery after multiple treatments. Currently, discussions on the recurrence mechanism after Eustachian tube balloon dilation mainly include the following factors: unclear assessment of the actual condition of the Eustachian tube lumen; pathological changes in the tympanic cavity and Eustachian tube mucosa cells, making functional recovery impossible; and postoperative collapse of the Eustachian tube lumen, failing to meet effective ventilation of the middle ear, and tympanic cavity effusion further aggravating the burden on the Eustachian tube, thus affecting the surgical efficacy. Therefore, maintaining the morphology of the dilated Eustachian tube based on reliable preoperative diagnosis is crucial for surgical success. In current medical practice, Eustachian tube stents can be used to treat Eustachian tube dysfunction and relieve problems such as ear blockage, hearing loss, and ear pain. Existing stent technologies mainly include non-degradable metal or plastic materials. These stents play a certain role in the treatment of diseases, but they also have some drawbacks, such as the potential for long-term tissue reactions and the need for surgical removal.

[0004] With advancements in materials science, biodegradable materials have attracted researchers' attention because these materials can be gradually absorbed by the body after fulfilling their function, thus reducing the need for secondary surgery to remove stents. Stents made of biodegradable materials can degrade rapidly after maintaining the patency of the Eustachian tube for a period, thereby reducing the risk of tissue hyperplasia. However, there are still technical barriers to using biodegradable materials in stent fabrication: because the ends of these stents are relatively easier to degrade, degradation at the ends can lead to two problems. First, the connection between the Eustachian tube and the middle ear loses effective support, making it difficult to maintain patency. Second, partial degradation of the stent can cause it to slip, further increasing the possibility of blockage at the Eustachian tube-middle ear connection. Summary of the Invention

[0005] The purpose of this invention is to provide a biodegradable Eustachian tube stent and a biodegradable Eustachian tube stent system to solve the problem that existing biodegradable Eustachian tube stents are prone to causing blockage at the junction of the Eustachian tube and the middle ear.

[0006] To solve the above-mentioned technical problems, the present invention provides a biodegradable Eustachian tube support, including a Eustachian tube receiving portion and a middle ear receiving portion connected to each other;

[0007] When the Eustachian tube receptacle is in an expanded state without external force, it is tubular and has a hollow, through-hole cavity; after being implanted into the Eustachian tube, the Eustachian tube receptacle is in the expanded state to open the Eustachian tube.

[0008] The middle ear receiving portion includes a linear base structure. When not subjected to external force, the base structure winds itself into a three-dimensional winding shape in space. After being implanted into the tympanic cavity, the base structure, in the three-dimensional winding shape, fills the area of ​​the tympanic cavity adjacent to the Eustachian tube to maintain the communication between the tympanic cavity and the Eustachian tube, while preventing the Eustachian tube receiving portion from sliding.

[0009] Both the Eustachian tube accommodating portion and the substrate structure are made of biodegradable materials.

[0010] Optionally, the biodegradable material is a composite material containing polylactic acid and magnesium.

[0011] Optionally, the axial length of the Eustachian tube receiving portion is 15mm to 31mm, and when the Eustachian tube receiving portion is in the expanded state, the radial dimension of its outer contour is 0.5mm to 1.3mm.

[0012] Optionally, the circumferential sidewall of the Eustachian tube receiving portion has a plurality of micropores, the pore diameter of which is 0.01mm to 0.1mm.

[0013] Optionally, when the Eustachian tube accommodating portion is in the expanded state, its outer contour shape shrinks axially in a direction away from the middle ear accommodating portion.

[0014] Optionally, the matrix structure includes a two-dimensional winding structure, which is formed by winding wire.

[0015] Optionally, the substrate structure is configured to unfold into a linear extension and be loaded into a conveying device under the action of an external force, for entering the tympanic cavity under the push of the conveying device; after being pushed into the tympanic cavity and released from the constraint of the conveying device, the substrate structure transforms into the three-dimensional winding shape.

[0016] Optionally, the Eustachian tube receiving portion is configured to retract or fold radially under the action of an external force to transition to a delivery state and be loaded into a delivery device; after being implanted into the Eustachian tube and the constraint of the delivery device is released, the Eustachian tube receiving portion transitions to the expanded state.

[0017] Optionally, in the delivery device, the Eustachian tube accommodating portion and the middle ear accommodating portion extending linearly are arranged along the axial direction of the delivery device.

[0018] To address the aforementioned technical problems, the present invention also provides a biodegradable Eustachian tube support system, comprising the biodegradable Eustachian tube support as described above, and further comprising a delivery device; the delivery device comprises a delivery tube and a pushing component; the delivery tube is used to accommodate the Eustachian tube accommodating portion and extend to the middle ear accommodating portion extending linearly; after the delivery tube passes through the tympanic membrane, the pushing component is used to push the biodegradable Eustachian tube support out axially within the delivery tube.

[0019] In summary, in the biodegradable Eustachian tube stent and biodegradable Eustachian tube stent system provided by the present invention, the biodegradable Eustachian tube stent includes a connected Eustachian tube receiving portion and a middle ear receiving portion; the Eustachian tube receiving portion is tubular when in an expanded state without external force, and has a hollow, through-hole cavity; after being implanted into the Eustachian tube, the Eustachian tube receiving portion is in the expanded state to open the Eustachian tube; the middle ear receiving portion includes a linear base structure, which, when not subjected to external force, winds itself into a three-dimensional winding shape in space; after being implanted into the tympanic cavity, the base structure is in the three-dimensional winding shape, filling the area of ​​the tympanic cavity adjacent to the Eustachian tube to maintain the communication between the tympanic cavity and the Eustachian tube, while preventing the Eustachian tube receiving portion from sliding; both the Eustachian tube receiving portion and the base structure are made of biodegradable materials.

[0020] This configuration allows the middle ear receptacle to fill the area adjacent to the tympanic cavity and eustachian tube while simultaneously opening the eustachian tube. Because the middle ear receptacle has a three-dimensional, wraparound shape with gaps, it maintains communication between the tympanic cavity and the eustachian tube. Furthermore, the middle ear receptacle acts as a mutual positioning element with the eustachian tube receptacle, maintaining its position, reducing or preventing slippage, and improving its stability. Attached Figure Description

[0021] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention.

[0022] Figure 1 This is a schematic diagram illustrating the implantation application scenario of the biodegradable Eustachian tube stent system according to an embodiment of the present invention.

[0023] Figure 2 This is a schematic diagram of a biodegradable Eustachian tube stent according to an embodiment of the present invention.

[0024] Figure 3 This is a schematic diagram of a biodegradable Eustachian tube stent mounted on a delivery device according to an embodiment of the present invention.

[0025] Figure 4 This is a schematic diagram of the Eustachian tube accommodating portion according to an embodiment of the present invention.

[0026] Figure 5a This is a schematic diagram of a two-dimensional winding structure according to an embodiment of the present invention.

[0027] Figure 5b This is a schematic diagram of the base structure of the three-dimensional winding form according to an embodiment of the present invention.

[0028] In the attached figures: 01-Tympanic membrane; 02-External auditory canal; 03-Tympanic cavity; 04-Eustral tube; 10-Eustral tube accommodating part; 11-Micropore; 20-Middle ear accommodating part; 21-Base structure; 22-Two-dimensional winding structure; 30-Conveying device; 31-Conveying tube; 32-Pushing assembly; 321-Pushing rod; 322-Piston. Detailed Implementation

[0029] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0030] As used herein, the singular forms “a,” “an,” “one,” and “the” include plural objects; the term “or” is generally used to include the meaning of “and / or”; the term “a number” is generally used to include the meaning of “at least one”; the term “at least two” is generally used to include the meaning of “two or more”; furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal end” and “distal end” generally refer to two corresponding parts, which include not only endpoints. The terms “proximal end” and “distal end” are defined herein with respect to a delivery device having an end for insertion into the human body and a control end extending outside the body. The term “proximal end” refers to the position closer to the control end extending outside the body of the delivery device, and the term “distal end” refers to the position closer to the end of the delivery device for insertion into the human body and therefore further away from the control end of the delivery device. Optionally, in applications involving manual or hand-operated handling, the terms "proximal" and "distal" are defined herein in relation to the operator, such as a surgeon or clinician. The term "proximal" refers to a position closer to the operator, and the term "distal" refers to a position closer to the delivery device and therefore further away from the operator. Furthermore, as used in this invention, terms such as "mounted," "connected," "linked," and "set" of one element on another should be interpreted broadly, generally indicating only a connection, coupling, engagement, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element. This connection, coupling, engagement, or transmission should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. Additionally, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as shown in the figures, with upward or up direction pointing towards the top of the corresponding figure, and downward or down direction pointing towards the bottom of the corresponding figure.

[0031] The purpose of this invention is to provide a biodegradable Eustachian tube stent and a biodegradable Eustachian tube stent system to solve the problem that existing biodegradable Eustachian tube stents easily cause blockage at the junction of the Eustachian tube and the middle ear. The following description refers to the accompanying drawings.

[0032] Figure 1This illustration shows an application scenario of the biodegradable Eustachian tube support system provided in this embodiment of the invention. Taking the human ear as an example, the tympanic membrane 01 serves as the boundary; outside the tympanic membrane 01 is the external auditory canal 02, and inside the tympanic membrane 01 is the middle ear, which includes the tympanic cavity 03. Under normal circumstances, the tympanic cavity 03 communicates with the nasopharynx via the Eustachian tube 04.

[0033] Please refer to Figure 1 and Figure 2 To address the problem of Eustachian tube obstruction, this invention provides a biodegradable Eustachian tube stent, comprising a connected Eustachian tube receiving portion 10 and a middle ear receiving portion 20. The Eustachian tube receiving portion 10, when in an expanded state without external force, is tubular and has a hollow, through-hole cavity. After being implanted into the Eustachian tube 04, the Eustachian tube receiving portion 10 is in the expanded state to open the Eustachian tube 04. The middle ear receiving portion 20 includes a linear base structure 21, which, when not subjected to external force, winds itself into a three-dimensional winding shape in space. After being implanted into the tympanic cavity 03, the base structure 21, in the three-dimensional winding shape, fills the area of ​​the tympanic cavity 03 adjacent to the Eustachian tube 04, maintaining communication between the tympanic cavity 03 and the Eustachian tube 04, while preventing the Eustachian tube receiving portion 10 from sliding. Both the Eustachian tube receiving portion 10 and the base structure 21 are made of biodegradable materials.

[0034] The inventors discovered that existing biodegradable stents used in the Eustachian tube often only consist of a tubular component implanted in the Eustachian tube 04. This type of biodegradable stent has several drawbacks in practical applications. For example, after implantation, the ends are relatively easier to degrade, causing the area connecting the Eustachian tube 04 to the middle ear to lose effective support and become difficult to maintain patency. Furthermore, partial degradation of the biodegradable stent may lead to slippage, causing a portion of the Eustachian tube 04 to lack effective support and become blocked again. Additionally, existing biodegradable stents are only implanted in the Eustachian tube 04, and research has found that the area of ​​the tympanic cavity 03 adjacent to the Eustachian tube 04 can also become blocked. Therefore, existing biodegradable stents cannot meet the requirements.

[0035] The biodegradable Eustachian tube stent provided in this embodiment includes two parts: the Eustachian tube receiving part 10 and the middle ear receiving part 20. The Eustachian tube receiving part 10 is used to implant and open the Eustachian tube 04. At the same time, the middle ear receiving part 20, which is connected to the Eustachian tube receiving part 10, can fill the area adjacent to the tympanic cavity 03 and the Eustachian tube 04. Since the middle ear receiving part 20 has a three-dimensional winding shape and has gaps, it can maintain the communication between the tympanic cavity 03 and the Eustachian tube 04.

[0036] On the other hand, it is understandable that when the middle ear accommodating portion 20 fills the tympanic cavity 03, the position of the eustachian tube accommodating portion 10 is essentially fixed due to its connection with it, preventing it from moving relative to the eustachian tube 04. Conversely, the eustachian tube 04 also limits the filling position of the middle ear accommodating portion 20. Thus, the middle ear accommodating portion 20 plays a mutual positioning role with the eustachian tube accommodating portion 10, maintaining the position of the eustachian tube accommodating portion 10, reducing or preventing slippage of the eustachian tube accommodating portion 10, and improving the stability of the eustachian tube accommodating portion 10.

[0037] It should be noted that the linear matrix structure 21 here only restricts the basic shape of the matrix structure 21 to be elongated, not that the matrix structure 21 must extend in a straight line. In some cases, the linear matrix structure 21 can be curved, coiled, or wrapped. That is, the extension direction of the matrix structure 21 can be curved, coiled, or wrapped.

[0038] In some embodiments, the linear substrate structure 21 can be wound in space and then shaped (e.g., heat-setting or chemical setting) to form a three-dimensional winding structure. Thus, when the substrate structure 21 is in its initial state without external force, it presents itself as a three-dimensional winding structure in space. Furthermore, since the substrate structure 21 itself is linear, the substrate structure 21 in its initial state of three-dimensional winding structure possesses a certain degree of elasticity and flexibility, and can deform under the action of a certain external force, for example, transforming into a linear extension (i.e., being approximately straightened). Figure 3 As shown. After the external force is removed, the base structure 21 can be transformed back to its initial state, restoring or roughly restoring to the shape of a three-dimensional surrounding structure in space, such as... Figure 2 As shown. The three-dimensional surrounding structure of the matrix structure 21 can fill and adapt to the complex anatomical structure of the tympanic cavity 03, while forming a large number of gaps to keep the area of ​​the tympanic cavity 03 adjacent to the Eustachian tube 04 unobstructed.

[0039] Optionally, the Eustachian tube receptacle 10 preferably has a certain degree of elasticity in the radial or circumferential direction, such as a certain degree of elasticity or self-recovery. After being implanted into the Eustachian tube 04, the Eustachian tube receptacle 10 can be converted to an expanded state based on elasticity or self-recovery, thereby opening the Eustachian tube 04, maintaining the openness of the Eustachian tube 04, and gradually degrading over a certain period of time (such as within 3 to 6 months). During the degradation process, the Eustachian tube receptacle 10 gradually loses its mechanical strength, but during this period it is sufficient to maintain the open state of the Eustachian tube 04 to allow the tissue to gradually heal during this period.

[0040] In one embodiment, both the Eustachian tube receptacle 10 and the substrate structure 21 are made of biodegradable materials. After a period of implantation, both the Eustachian tube receptacle 10 and the middle ear receptacle 20 are biodegradable, avoiding the long-term complications and need for secondary surgery associated with traditional stents. How to control the degradation rate of the material to adapt to the recovery speed of different patients, and how to ensure that the mechanical properties of the material do not fail prematurely during degradation, are considerations in the selection of biodegradable materials. Studies have found that magnesium and magnesium alloys exhibit good biocompatibility and suitable degradation rates in applications. Some polymers, such as polylactic acid (PLA), also have suitable biocompatibility and biodegradability. These materials can gradually degrade in vivo, and the degradation products are non-toxic and do not cause long-term effects on the human body. Preferably, the biodegradable material of the Eustachian tube receptacle 10 and the substrate structure 21 is a composite material containing polylactic acid and magnesium. The composite method can be, for example, a magnesium or magnesium alloy core wrapped with a polylactic acid coating layer, or polylactic acid, magnesium, or magnesium alloy respectively forming filaments, which are then woven into shapes, etc. Those skilled in the art can configure the ratio and compounding method between polylactic acid and magnesium or magnesium alloy according to the actual required degradation time, and this embodiment is not limited in this respect.

[0041] The materials of the Eustachian tube receiving portion 10 and the middle ear receiving portion 20 can be the same or different. The degradation rates of the Eustachian tube receiving portion 10 and the middle ear receiving portion 20 can be the same or different. The connection between the Eustachian tube receiving portion 10 and the middle ear receiving portion 20 can be, for example, welding, fusion, or bonding, and this embodiment is not limited to these methods.

[0042] Optionally, the axial length of the Eustachian tube accommodating portion 10 is 15mm to 31mm, and when the Eustachian tube accommodating portion 10 is in the expanded state, the radial dimension of its outer contour is 0.5mm to 1.3mm. Please refer to... Figure 4 When expanded, the Eustachian tube receiving portion 10 is approximately tubular, with a preferably circular or elliptical cross-section. Its hollow, permeable interior effectively maintains the openness of the Eustachian tube 04. The axial length of the Eustachian tube receiving portion 10 is slightly shorter than the length of the Eustachian tube 04, and can be selected according to the specific circumstances of different patients. The axial length of the Eustachian tube receiving portion 10 is preferably 18mm to 28mm. The radial dimension of the outer contour of the Eustachian tube receiving portion 10 is preferably slightly larger than the inner diameter of the Eustachian tube 04, so that the Eustachian tube receiving portion 10 can be well secured within the Eustachian tube 04.

[0043] Preferably, when the Eustachian tube receiving portion 10 is in the expanded state, its outer contour shape decreases axially in the direction away from the middle ear receiving portion 20. Based on the anatomical structure of the Eustachian tube 04, the Eustachian tube receiving portion 10 can be configured with one end larger than the other. The outer diameter corresponding to the cartilaginous end of the Eustachian tube can be relatively slightly smaller, for example, 0.5mm to 1.1mm, preferably 0.8mm, while the outer diameter corresponding to the end away from the cartilaginous end of the Eustachian tube can be relatively slightly larger, for example, 0.7mm to 1.3mm, preferably 1.0mm.

[0044] Understandably, after the Eustachian tube accommodating portion 10 is implanted into the Eustachian tube 04, it may be limited and constrained by the Eustachian tube 04, and may not fully transition to the expanded state, meaning it may not be able to fully expand, and may deform to adapt to the bending and twisting of the Eustachian tube 04. Therefore, it should be understood that the aforementioned shape and size of the Eustachian tube accommodating portion 10 in the expanded state refer to the ideal state of the Eustachian tube accommodating portion 10 when it is not subjected to external force, and not to the shape and size of the Eustachian tube accommodating portion 10 after implantation.

[0045] For preferred options, please refer to [the provided text]. Figure 4 The circumferential sidewall of the Eustachian tube receiving portion 10 has a plurality of micropores 11, the pore diameter of which is 0.01 mm to 0.1 mm. More preferably, the pore diameter of the micropores 11 is 0.05 mm. The micropores 11 can promote tissue growth of the Eustachian tube 04 into the Eustachian tube receiving portion 10, enhancing the fixation effect of the Eustachian tube 04. It should be noted that the micropores 11 can be circular, but are not limited to being circular. In one embodiment, the shape of the micropores 11 is not limited, but preferably, the area of ​​the micropores 11 is comparable to the area of ​​a circular hole with a pore diameter of 0.01 mm to 0.1 mm. In some embodiments, the Eustachian tube receiving portion 10 can be made from a tubular substrate by cutting or laser drilling. In other embodiments, the Eustachian tube receiving portion 10 can be formed by weaving filaments, wherein the mesh formed by the filament weaving is configured as the micropores 11.

[0046] Please refer to Figure 5a and Figure 5b In some embodiments, the substrate structure 21 includes a two-dimensional winding structure 22; the two-dimensional winding structure 22 is formed by winding filaments; the two-dimensional winding structure 22 may include, for example, a spring coil formed by spiral winding, or a wavy structure or a sawtooth structure formed by bending along a line.

[0047] In one example, the two-dimensional winding structure 22 includes a spring coil formed by winding wire. The wire is spirally wound along a certain axis to form the two-dimensional winding structure 22, and then shaped, such as... Figure 5aAs shown. At this point, the two-dimensional winding structure 22 is roughly in the shape of a spring coil. It is understood that the axis of the two-dimensional winding structure 22 is not limited to a straight line, but can be bent or wound. Preferably, the wire diameter is 0.1mm~0.5mm; the outer diameter of the two-dimensional winding structure 22 is 0.5mm~1.0mm; and the pitch of the two-dimensional winding structure 22 is 0.2mm~0.5mm. It should be noted that the outer diameter of the two-dimensional winding structure 22 refers to the radial dimension of the outer contour of the spring coil formed by the winding of the wire. The pitch of the two-dimensional winding structure 22 refers to the distance between corresponding points of two adjacent spirals of the spirally wound wire in the axial direction. With this configuration, using the two-dimensional winding structure 22 as the base structure 21 to form a three-dimensional winding structure can effectively improve the elasticity and support performance of the three-dimensional winding structure. Furthermore, in some embodiments, the two-dimensional winding structure 22 can be used to further increase the porosity, which on the one hand facilitates tissue ingrowth and improves embedding performance, and on the other hand can improve the drug loading performance of the matrix structure 21 when drug attachment is required.

[0048] Preferably, the pitch of the two-dimensional winding structure 22 remains constant, meaning the wire is wound at a certain pitch, and the distance between two adjacent turns of the formed spring coil is the same in the axial direction. In other embodiments, the pitch of the two-dimensional winding structure 22 can also be varied, meaning the spring coil is not homogeneous in the axial direction, but rather uneven in density. Those skilled in the art can select parameters such as the wire diameter, the outer diameter of the two-dimensional winding structure 22, and the pitch according to actual needs.

[0049] It is understood that this embodiment is not limited to using a two-dimensional winding structure 22 to form the base structure 21. In other embodiments, the base structure 21 may also include simple solid filament, hollow filament, multi-bundle filament, or braided filament, or the base structure 21 may include two or more configurations, such as a part of the base structure 21 being a two-dimensional winding structure 22 and another part of the base structure 21 being a solid filament, etc. The present invention is not limited to this.

[0050] The biodegradable Eustachian tube stent provided in this embodiment can be implanted in two ways: one is direct implantation during open surgery; the other is through minimally invasive surgery, using an endoscope and a delivery device 30 (please refer to...). Figure 1 and Figure 3 The device is inserted into the middle ear after puncturing the tympanic membrane 01. The method of implantation using the delivery device 30 will be further explained below.

[0051] The delivery device 30 includes a delivery tube 31 and a pushing component 32; the delivery tube 31 is used to accommodate the Eustachian tube accommodating portion 10 and extend to the middle ear accommodating portion 20 that extends in a linear manner; after the delivery tube 31 passes through the tympanic membrane 01, the pushing component 32 is used to push the biodegradable Eustachian tube support out axially in the delivery tube 31.

[0052] In an alternative example, the delivery tube 31 is preferably a hollow tubular piece, the distal end of which may be beveled to form a sharp point suitable for puncture. The material of the delivery tube 31 may be medical-grade stainless steel, preferably such as 304 stainless steel, 316 stainless steel, or 430 stainless steel.

[0053] Optionally, the pushing assembly 32 includes a pushing rod 321 and a piston 322. The cross-sectional shape of the piston 322 is adapted to the inner cavity shape of the delivery tube 31, allowing the piston 322 to move axially along the delivery tube 31 and substantially fill the entire inner cavity cross-section of the delivery tube 31. The pushing rod 321 is connected to the proximal end of the piston 322 and extends out of the proximal opening of the delivery tube 31 for operator manipulation.

[0054] Furthermore, the Eustachian tube receiving portion 10 is configured to retract or fold radially under external force to transition to a delivery state and be loaded into the delivery device 30; the base structure 21 is configured to unfold linearly under external force and be loaded into the delivery device 30. Even further, in the delivery device 30, the Eustachian tube receiving portion 10 and the middle ear receiving portion 20, which unfolds linearly, are arranged axially along the delivery device 30, wherein the Eustachian tube receiving portion 10 is located on the distal side.

[0055] In one example, the Eustachian tube receiving portion 10 can be folded and retracted, and the base structure 21 can be straightened and loaded into the delivery tube 31. At this time, both the Eustachian tube receiving portion 10 and the base structure 21 are constrained by the wall of the delivery tube 31, so that the two maintain a roughly axially arranged shape.

[0056] Next, the distal end of the delivery tube 31 is punctured through the tympanic membrane 01 and extended into the tympanic cavity 03. After reaching the connection between the tympanic cavity 03 and the Eustachian tube 04, the push rod 321 is pushed distally. Under the push of the piston 322, the Eustachian tube receiving portion 10 is implanted into the Eustachian tube 04, and the constraint from the delivery device 30 (referring to the delivery tube 31) is released. The Eustachian tube receiving portion 10 then transitions to an expanded state, thereby opening the Eustachian tube 04. Further, the push rod 321 is pushed distally, and the matrix structure 21 is pushed into the tympanic cavity 03, releasing the constraint from the delivery device 30 (referring to the delivery tube 31). The matrix structure 21 then transitions to a three-dimensional structure in space. After implantation is completed, the delivery device 30 is withdrawn.

[0057] This invention also provides a biodegradable Eustachian tube support system, which includes the biodegradable Eustachian tube support as described above, and a delivery device 30 as described above. The delivery tube 31 of the delivery device 30 is used to accommodate the Eustachian tube receiving portion 10 and extends to the middle ear receiving portion 20 extending linearly; after the delivery tube 31 passes through the tympanic membrane 01, the pushing component 32 of the delivery device 30 is used to push the biodegradable Eustachian tube support out axially within the delivery tube 31.

[0058] In one embodiment, the biodegradable Eustachian tube stent can be pre-placed in the delivery device 30 before leaving the factory, so it does not need to be loaded during use and can be used directly.

[0059] In summary, in the biodegradable Eustachian tube stent and biodegradable Eustachian tube stent system provided by the present invention, the biodegradable Eustachian tube stent includes a connected Eustachian tube receiving portion and a middle ear receiving portion; the Eustachian tube receiving portion is tubular when in an expanded state without external force, and has a hollow, through-hole cavity; after being implanted into the Eustachian tube, the Eustachian tube receiving portion is in the expanded state to open the Eustachian tube; the middle ear receiving portion includes a linear base structure, which, when not subjected to external force, winds itself into a three-dimensional winding shape in space; after being implanted into the tympanic cavity, the base structure is in the three-dimensional winding shape, filling the area of ​​the tympanic cavity adjacent to the Eustachian tube to maintain the communication between the tympanic cavity and the Eustachian tube, while preventing the Eustachian tube receiving portion from sliding; both the Eustachian tube receiving portion and the base structure are made of biodegradable materials. This configuration allows the middle ear receptacle to fill the area adjacent to the tympanic cavity and eustachian tube while simultaneously opening the eustachian tube. Because the middle ear receptacle has a three-dimensional, wraparound shape with gaps, it maintains communication between the tympanic cavity and the eustachian tube. Furthermore, the middle ear receptacle acts as a mutual positioning element with the eustachian tube receptacle, maintaining its position, reducing or preventing slippage, and improving its stability.

[0060] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A biodegradable Eustachian tube stent, characterized in that, Including the connected Eustachian tube accommodating part and the middle ear accommodating part; When the Eustachian tube receptacle is in an expanded state without external force, it is tubular with a circular or elliptical cross-section and a hollow, through-hole cavity. The Eustachian tube receptacle is elastic in the circumferential direction. After being implanted into the Eustachian tube, the Eustachian tube receptacle is in the expanded state to open the Eustachian tube. The middle ear receiving portion includes a linear base structure. When not subjected to external force, the base structure winds itself into a three-dimensional winding shape in space. After being implanted into the tympanic cavity, the base structure, in the three-dimensional winding shape, fills the area of ​​the tympanic cavity adjacent to the Eustachian tube to maintain the communication between the tympanic cavity and the Eustachian tube, while preventing the Eustachian tube receiving portion from sliding. Both the Eustachian tube accommodating portion and the substrate structure are made of biodegradable materials; The circumferential sidewall of the Eustachian tube receiving portion has multiple micropores with a pore diameter of 0.01 mm to 0.1 mm. The micropores are used to promote the growth of Eustachian tube tissue into the Eustachian tube receiving portion.

2. The biodegradable Eustachian tube stent according to claim 1, characterized in that, The biodegradable material is a composite material containing polylactic acid and magnesium.

3. The biodegradable Eustachian tube stent according to claim 1, characterized in that, The axial length of the Eustachian tube accommodating part is 15mm to 31mm, and when the Eustachian tube accommodating part is in the expanded state, the radial dimension of its outer contour is 0.5mm to 1.3mm.

4. The biodegradable Eustachian tube stent according to claim 1, characterized in that, When the Eustachian tube accommodating portion is in the expanded state, its outer contour shape shrinks axially in a direction away from the middle ear accommodating portion.

5. The biodegradable Eustachian tube stent according to claim 1, characterized in that, The matrix structure includes a two-dimensional winding structure, which is formed by winding wire.

6. The biodegradable Eustachian tube stent according to claim 1, characterized in that, The matrix structure is configured to unfold into a linear extension under the action of external force and be loaded into a conveying device for entering the tympanic cavity under the push of the conveying device; After being pushed into the tympanic cavity and released from the constraints of the delivery device, the substrate structure transforms into the three-dimensional winding shape.

7. The biodegradable Eustachian tube stent according to claim 1, characterized in that, The Eustachian tube receiving portion is configured to contract radially under the action of an external force to transition to a delivery state and be loaded into a delivery device; after being implanted into the Eustachian tube and released from the constraints of the delivery device, the Eustachian tube receiving portion transitions to the expanded state.

8. The biodegradable Eustachian tube stent according to claim 1, characterized in that, In the delivery device, the Eustachian tube accommodating portion and the middle ear accommodating portion extending linearly are arranged along the axial direction of the delivery device.

9. A biodegradable Eustachian tube support system, characterized in that, The device includes a biodegradable Eustachian tube stent according to any one of claims 1 to 8, and further includes a delivery device; the delivery device includes a delivery tube and a pushing assembly; the delivery tube is used to receive the Eustachian tube receiving portion and extend to the middle ear receiving portion extending linearly; after the delivery tube passes through the tympanic membrane, the pushing assembly is used to push the biodegradable Eustachian tube stent axially out of the delivery tube.

Images